Endometrial Cancer Clinical Trial
Official title:
Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer: A Prospective Randomized Trial
NCT number | NCT03900104 |
Other study ID # | CEIN |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | January 15, 2020 |
Verified date | February 2020 |
Source | Kocaeli University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.
Status | Completed |
Enrollment | 81 |
Est. completion date | January 15, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Endometrial Cancer Patients - Suitable patients for surgical staging Exclusion Criteria: - Patients who cannot undergo cervical or transcervical endometrial injection - Pathology did not confirm endometrial cancer - Sarcoma of the uterine corpus - If a 90-day follow-up was not feasible |
Country | Name | City | State |
---|---|---|---|
Turkey | Kocaeli University | Kocaeli |
Lead Sponsor | Collaborator |
---|---|
Kocaeli University |
Turkey,
Niikura H, Kaiho-Sakuma M, Tokunaga H, Toyoshima M, Utsunomiya H, Nagase S, Takano T, Watanabe M, Ito K, Yaegashi N. Tracer injection sites and combinations for sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):299-303. doi: 10.1016/j.ygyno.2013.08.018. Epub 2013 Aug 27. — View Citation
Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detected pelvic and paraaortic sentinel lymph node numbers | Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging) | Postoperative 30 days | |
Secondary | Numbers adverse events | Number of adverse events associated with the surgery | Postoperative 90 days |
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